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Medical Device Establishment

FDA Medical Device Establishment
Registration & U.S. Agent

Recognized as one of the best FDA U.S. Agents for medical device manufacturers, Orionex handles Establishment Registration, Device Listing, UDI/GUDID submission, and 510(k)-adjacent U.S. Agent representation under CDRH's 21 CFR Part 807 requirements.

📅 Already registered? Device registration renews annually — see our 2026 renewal guide (Oct 1 – Dec 31, FY2026 fee: $11,423).

Register Your Device Establishment → Free Consultation
1,200+
Clients Served
15+
Years Experience
98%
First-Round Acceptance
60+
Countries
Orionex Regulatory Solutions — Licensed FDA U.S. Agent based in Casper, Wyoming USA
✦ Official U.S. Regulatory Partner ✦
U.S. Agent for Device Makers
Casper, Wyoming · Incorporated USA
✅ No Hidden Fees — Upfront Pricing
🔒 Secure Stripe & PayPal Checkout
⚡ Work Begins Within 1 Business Day
📜 Certificate of Registration Included
🌐 Serving Clients in 60+ Countries

What's Included

What's Included in Device Registration

From establishment registration through 510(k)-adjacent support, we cover every CDRH requirement your device needs to reach the U.S. market.

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Device Registration & U.S. Agent

Establishment Registration filed in FURLS, plus U.S. Agent designation required under 21 CFR Part 807 for every foreign device manufacturer.

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Device Listing / UDI / GUDID

Product listing for each device model, Unique Device Identifier (UDI) assignment, and GUDID database submission.

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FDA 510(k) Submission Support

Guidance and documentation support for Premarket Notification 510(k) submissions to demonstrate substantial equivalence.

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Medical Device Label Review

Label and labeling review against 21 CFR Part 801 requirements, including UDI placement and required warnings.

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QSR / Quality System Consulting

Advisory on Quality System Regulation (21 CFR Part 820) compliance ahead of FDA inspection readiness.

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Renewal & Ongoing Support

Annual establishment registration renewal reminders (October 1 – December 31 window) and a dedicated account manager.

Who Needs This

Who Needs Device Establishment Registration?

Any foreign establishment that manufactures, prepares, propagates, compounds, assembles, or processes a medical device for the U.S. market must register with FDA under 21 CFR Part 807 — regardless of device class (I, II, or III).

This includes contract manufacturers, specification developers, repackagers, and relabelers — not just the original device designer. Every registered establishment must also designate a U.S. Agent based physically in the United States.

  • Class I, II, and III medical device manufacturers exporting to the U.S.
  • Contract manufacturers, specification developers, repackagers & relabelers
  • Companies preparing a 510(k) Premarket Notification submission
  • Manufacturers needing UDI/GUDID listing for new device models
  • Facilities switching U.S. Agents ahead of the Oct–Dec renewal window
Transparent Pricing

Device Establishment Registration

$550/year
Typically completed in 5–10 business days
  • FDA Establishment Registration
  • U.S. Agent Designation (1 year)
  • Official Certificate of Registration
  • Device listing guidance included
Register Your Device Establishment →

Simple Process

From Inquiry to Certificate in 4 Steps

Our streamlined process gets your medical device establishment registered and compliant fast — without the complexity.

1

Free Consultation

Tell us about your product and market. We assess your needs at no cost.

2

Document Collection

We provide a clear checklist and guide you through gathering every required document.

3

FDA Submission

We prepare and file directly with FDA. Our CDRH-focused team has an unmatched track record on first-cycle acceptance for device establishment filings.

4

Certificate Delivered

You receive your official FDA registration number and Certificate of Registration.

Our Credentials

Why Orionex Is a Trusted FDA Agent for Device Makers

Orionex is physically incorporated in Casper, Wyoming, with a dedicated CDRH-focused team that has guided device manufacturers through registrations — and complex 510(k) submissions — for over 15 years.

98%
First-Round Acceptance
15+
Years Experience
1,200+
Clients Served
🩺
CDRH
Medical Devices, UDI & 510(k) Submissions
🔖
UDI / GUDID
Unique Device Identifier & Listing Database
⚙️
QSR
21 CFR Part 820 Quality System Readiness
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Label Review
21 CFR Part 801 Device Labeling Compliance

FAQ

Medical Device Registration — FAQ

Common questions from device manufacturers about FDA establishment registration.

Do all medical device classes need FDA establishment registration?+

Yes. Establishment registration under 21 CFR Part 807 applies to Class I, II, and III device manufacturers alike — registration itself does not depend on device classification. However, whether you also need a 510(k) or PMA clearance does depend on your device's class and intended use.

What's the difference between establishment registration and device listing?+

Establishment registration identifies your facility to FDA. Device listing identifies each specific device model your facility produces. Both are required, and both are filed through FDA's FURLS/DRLM system — Orionex handles both as part of the same engagement.

How much does medical device FDA registration cost?+

Orionex charges $550/year for Establishment Registration, U.S. Agent designation, and an official Certificate of Registration. 510(k) submission support, UDI assignment, and label review are available as add-on services depending on scope.

Do I need a 510(k) submission for my device?+

It depends on your device's classification and predicate devices. Most Class II devices require 510(k) clearance before U.S. market entry; some Class I devices are exempt. Orionex can assess your specific device and advise whether 510(k), PMA, or an exemption applies.

When does device establishment registration need to be renewed?+

Establishment registration must be renewed annually between October 1 and December 31 for the following fiscal year. Orionex sends proactive renewal reminders well ahead of this window so your registration never lapses.

What is the best FDA agent for medical device manufacturers?+

Look for a U.S. Agent with direct CDRH experience — not just general FDA knowledge — physically incorporated in the USA, offering transparent pricing and a verifiable track record with 510(k)-track devices. Orionex Regulatory Solutions has guided device manufacturers through registrations and complex submissions, including cases where other consultants estimated significantly longer timelines.

Ready to Register Your Device Establishment?

Transparent pricing. CDRH expertise. Certificate of Registration included.

Register Your Device Establishment → Free Consultation